Sirtex Medical Inc. Announces 19 Percent Dose Sales Growth of SIR-Spheres® Y-90 resin microspheres in Fiscal Year 2016
August 25 2016 - 8:10AM
Business Wire
Company Reports Significant Increase in Both
Referring Physicians and Hospitals Certified to Administer
Procedure
Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited
(ASX:SRX), a leading manufacturer of targeted liver cancer
therapies, today announced dose sales of SIR-Spheres® Y-90 resin
microspheres grew 19 percent in the Americas region for the fiscal
year ending June 30, 2016, compared to the previous corresponding
period. Revenue climbed to $134.8M, with more than 8,420 doses
being supplied across the region. SIR-spheres Y-90 resin
microspheres are available at more than 550 hospitals in the
region, up 14 percent from the previous fiscal year.
“The Americas region continues to perform strongly, which is
directly reflected through the outstanding sales results achieved
in this challenging market,” said Kevin Richardson, CEO Americas,
Sirtex Medical Inc. “We continue to execute against our strategic
initiatives and have made significant progress during this period
in the U.S. market by continuing to increase the awareness and
education about SIR-Spheres Y-90 resin microspheres therapy within
the oncology community. We have also made substantial inroads in
our other markets including the recent approval of SIR-Spheres Y-90
resin microspheres for the treatment of unresectable liver tumors
in Canada and continued market development activities with key
opinion leaders in Latin America.”
Gilman Wong, CEO of Sirtex Medical, commented, “The strong
financial performance in fiscal year 2016 reflects the continued
execution of our strategies that seek to expand our global
footprint, build clinician awareness and referrals, and increase
reimbursement coverage for patients suffering from liver
cancer.”
Sirtex continues to generate and present additional Level 1
clinical data from the SIRFLOX study, which was first presented at
the American Society of Clinical Oncology (ASCO) Annual Meeting in
2015. More recently, the company released supplemental data further
supporting the enduring effect that SIR-Spheres Y-90 resin
microspheres can provide to patients when combined with
chemotherapy.
“Sirtex is focused on educating the many medical professionals
in the Americas region to support improved clinical outcomes for
patients facing liver tumors resulting from metastatic colorectal
cancer, as well as extending relevant information and education
directly to patients in the U.S. market,” continued Richardson. “We
are now in a position where our teams can fully discuss the SIRFLOX
data with our customers. Looking forward, we eagerly await the
overall survival data from the combined FOXFIRE, FOXFIRE Global and
SIRFLOX studies, in 2017, representing more than 1,100
patients.”
The Americas region remains a key driver for dose sales and
revenue growth globally, currently representing 70.6 percent of the
company’s dose sales and 79.7 percent of revenue. Dose sales in
Europe, Middle East and Africa (EMEA) of 2,528 units were up 11.2
percent compared to the same period last year, with revenues
growing 20 percent. Dose sales in the Asia Pacific (APAC) region of
983 units increased 8.9 percent compared to the same period last
year with revenue growth of 20.9 percent.
Sirtex’s two main Phase III studies in primary liver cancer,
SARAH and SIRveNIB, completed patient recruitment by the end of the
2016 financial year. The results of these studies are expected in
the first half of calendar year 2017.
About Selective Internal Radiation Therapy using
SIR-Spheres® Y-90 resin microspheres
SIR-Spheres® Y-90 resin microspheres are a medical device used
in an interventional radiology procedure known as selective
internal radiation therapy (SIRT), or radioembolization, which
targets high doses of radiation directly to liver tumors. The
treatment consists of tens of millions of radioactive Y-90 coated
resin particles, each no bigger in diameter than a human hair.
Interventional radiologists inject these resin particles, or
microspheres, into the hepatic artery via a catheter inserted into
the femoral artery through an incision in the groin. The Y-90 resin
microspheres become lodged in the capillaries that surround liver
tumors, where they deliver a high dose of short-range (mean 2.5 mm;
maximum 11 mm) beta radiation to the liver tumors, while sparing
healthy liver tissue. The low specific gravity of the Y-90 resin
microspheres allows the blood flow to evenly distribute the
radioactivity within and around the liver tumors.
Available at more than 550 treatment centers in the U.S., more
than 67,000 doses of SIR-Spheres Y-90 resin microspheres have been
supplied worldwide.
SIR-Spheres Y-90 resin microspheres have a Premarket Approval
(PMA) by the FDA and are indicated for the treatment of
non-resectable metastatic liver tumors from primary colorectal
cancer in combination with intra-hepatic artery chemotherapy using
floxuridine. SIR-Spheres Y-90 resin microspheres are approved for
the treatment of inoperable liver tumors in Australia, the European
Union, Argentina, Brazil, Canada and several countries in Asia,
such as India and Singapore.
About Sirtex
Sirtex Medical Limited (ASX:SRX) is an Australian-based global
healthcare business working to improve outcomes in people with
cancer. Our current lead product is a targeted radiation therapy
for liver cancer called SIR-Spheres Y-90 resin microspheres. More
than 67,000 doses have been supplied to treat patients with liver
cancer at more than 1,000 medical centers in over 40 countries.
For more information, visit www.sirtex.com.
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty
Ltd.
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For Sirtex Medical Inc.Elizabeth Romero,
919-457-0749elizabeth.romero@fleishman.com
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